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510(k) DEN170058

MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay by Memorial Sloan-Kettering Cancer Center — Product Code PZM

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 15, 2017
Date Received
September 25, 2017
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Next Generation Sequencing Based Tumor Profiling Test
Device Class
Class II
Regulation Number
866.6080
Review Panel
PA
Submission Type

A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens obtained from patients diagnosed with malignant solid neoplasms using targeted next-generation sequencing.

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